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No. 49 of 2020 Determinations/Veterans' Entitlements as made
This instrument determines the Statement of Principles concerning diabetes mellitus (Balance of Probabilities).
Administered by: Veterans' Affairs
Registered 29 Jun 2020
Table of contents.

RMA-Red

 

Statement of Principles

concerning

DIABETES MELLITUS
 (Balance of Probabilities)

(No. 49 of 2020)

The Repatriation Medical Authority determines the following Statement of Principles under subsection 196B(3) of the Veterans' Entitlements Act 1986.

 

Dated      26 June 2020

 

 

 

 

 

The Common Seal of the
Repatriation Medical Authority
was affixed to this instrument
at the direction of:

 

RMA Chairperson signature

 

Professor Nicholas Saunders AO

Chairperson

 

 

  

Contents

1          Name........................................................................................................................................... 3

2          Commencement........................................................................................................................ 3

3          Authority..................................................................................................................................... 3

4          Repeal......................................................................................................................................... 3

5          Application................................................................................................................................. 3

6          Definitions.................................................................................................................................. 3

7          Kind of injury, disease or death to which this Statement of Principles relates............... 3

8          Basis for determining the factors........................................................................................... 4

9          Factors that must exist............................................................................................................. 4

10        Relationship to service............................................................................................................. 9

11        Factors referring to an injury or disease covered by another Statement of Principles. 9

Schedule 1 - Dictionary........................................................................................... 10

1          Definitions.................................................................................................................................. 10

 

 


 

1               Name

This is the Statement of Principles concerning diabetes mellitus (Balance of Probabilities) (No. 49 of 2020).

2               Commencement

This instrument commences on 27 July 2020.

3               Authority

This instrument is made under subsection 196B(3) of the Veterans' Entitlements Act 1986.

4               Repeal

The Statement of Principles concerning diabetes mellitus No. 90 of 2011 (Federal Register of Legislation No. F2011L01451) made under subsections 196B(3) and (8) of the VEA is repealed.

5               Application

This instrument applies to a claim to which section 120B of the VEA or section 339 of the Military Rehabilitation and Compensation Act 2004 applies.

6               Definitions

The terms defined in the Schedule 1 - Dictionary have the meaning given when used in this instrument.

7               Kind of injury, disease or death to which this Statement of Principles relates

(1)          This Statement of Principles is about diabetes mellitus and death from diabetes mellitus.

Meaning of diabetes mellitus

(2)          For the purposes of this Statement of Principles, diabetes mellitus:

(a)          means persistent hyperglycaemia characterised by either:

(i)            two positive laboratory blood tests on separate days showing:

A.           a fasting plasma glucose concentration of at least 7.0 millimoles per litre; or

B.            a plasma glucose concentration of at least 11.1 millimoles per litre two hours after ingestion of 75 grams of glucose on a baseline fasting state (glucose tolerance test); or

C.            an HbA1c level of at least 6.5%; or

(ii)          an episode of diabetic ketoacidosis or hyperosmolar hyperglycaemic state with a blood glucose level of at least 11.1 millimoles per litre; and

(b)          includes:

(i)            drug-induced diabetes mellitus;

(ii)          gestational diabetes mellitus;

(iii)        primary diabetes mellitus;

(iv)        secondary diabetes mellitus;

(v)          type 1 diabetes mellitus; and

(vi)        type 2 diabetes mellitus; and

Note: type 1 diabetes mellitus and type 2 diabetes mellitus are defined in the Schedule 1 – Dictionary.

(c)          excludes impaired glucose tolerance.

(3)          While diabetes mellitus attracts ICD‑10‑AM code E10, E11, E12, E13 or E14, in applying this Statement of Principles the meaning of diabetes mellitus is that given in subsection (2).

(4)          For subsection (3), a reference to an ICD-10-AM code is a reference to the code assigned to a particular kind of injury or disease in The International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification (ICD-10-AM), Tenth Edition, effective date of 1 July 2017, copyrighted by the Independent Hospital Pricing Authority, ISBN 978-1-76007-296-4.

Death from diabetes mellitus

(5)          For the purposes of this Statement of Principles, diabetes mellitus, in relation to a person, includes death from a terminal event or condition that was contributed to by the person's diabetes mellitus.

Note: terminal event is defined in the Schedule 1 – Dictionary.

8               Basis for determining the factors

On the sound medical‑scientific evidence available, the Repatriation Medical Authority is of the view that it is more probable than not that diabetes mellitus and death from diabetes mellitus can be related to relevant service rendered by veterans or members of the Forces under the VEA, or members under the MRCA.

Note: MRCA, relevant service and VEA are defined in the Schedule 1 – Dictionary.

9               Factors that must exist

At least one of the following factors must exist before it can be said that, on the balance of probabilities, diabetes mellitus or death from diabetes mellitus is connected with the circumstances of a person's relevant service:

(1)          having an endocrine disorder from the specified list of endocrine disorders before the clinical onset of diabetes mellitus;

Note: specified list of endocrine disorders is defined in the Schedule 1 - Dictionary.

(2)          having a solid organ transplant or bone marrow transplant before the clinical onset of diabetes mellitus;

(3)          having glucocorticoid therapy as specified, before the clinical onset of diabetes mellitus, and where the glucocorticoid therapy as specified has ceased or decreased, the last dose of the therapy was received within the 30 days before the clinical onset of diabetes mellitus;

Note: glucocorticoid therapy as specified is defined in the Schedule 1 - Dictionary.

(4)          being treated with a drug from the Specified List 1 of drugs, which cannot be ceased or substituted, for at least the seven days before the clinical onset of diabetes mellitus;

Note: Specified List 1 of drugs is defined in the Schedule 1 - Dictionary.

(5)          being treated with a drug from the antidepressant or antipsychotic classes of drugs, which cannot be ceased or substituted, for at least the three months before the clinical onset of diabetes mellitus;

(6)          for type 1 diabetes mellitus only:

(a)          undergoing surgery to the pancreas before the clinical onset of diabetes mellitus;

(b)          having a specified pathological condition involving the pancreas before the clinical onset of diabetes mellitus;

Note: specified pathological condition involving the pancreas is defined in the Schedule 1 - Dictionary.

(c)          having haemolytic uraemic syndrome before the clinical onset of diabetes mellitus;

Note: haemolytic uraemic syndrome is defined in the Schedule 1 - Dictionary.

(d)         ingesting N-3-pyridyl methyl-N'-p-nitrophenyl urea (Vacor) within the 30 days before the clinical onset of diabetes mellitus; or

(e)          being treated with interferon alpha within the six months before the clinical onset of diabetes mellitus;

(7)          for type 2 diabetes mellitus only:

(a)          having smoked at least five pack-years of tobacco products before the clinical onset of diabetes mellitus, and where smoking has permanently ceased, the clinical onset of diabetes mellitus has occurred within 15 years of cessation;

Note: pack-year of tobacco products is defined in the Schedule 1 - Dictionary.

(b)          being exposed to second-hand smoke for at least 5,000 hours before the clinical onset of diabetes mellitus, and where exposure to second-hand smoke has permanently ceased, the clinical onset of diabetes mellitus has occurred within 15 years of cessation;

Note: being exposed to second-hand smoke is defined in the Schedule 1 - Dictionary.

(c)          being overweight or obese for at least five years before the clinical onset of diabetes mellitus;

Note: being overweight or obese is defined in the Schedule 1 - Dictionary.

(d)         an inability to undertake moderate physical activity of at least four METs for at least the five years before the clinical onset of diabetes mellitus;

Note: MET is defined in the Schedule 1 - Dictionary.

(e)          having cirrhosis of the liver at the time of the clinical onset of diabetes mellitus;

(f)           having non-alcoholic steatohepatitis at the time of the clinical onset of diabetes mellitus;

(g)          having infection with human immunodeficiency virus before the clinical onset of diabetes mellitus;

(h)          having infection with hepatitis C virus before the clinical onset of diabetes mellitus;

(i)            having depressive disorder at the time of the clinical onset of diabetes mellitus;

(j)            having bipolar disorder at the time of the clinical onset of diabetes mellitus;

(k)          having schizophrenia at the time of the clinical onset of diabetes mellitus;

(l)            having bilateral orchiectomy before the clinical onset of diabetes mellitus;

(m)        having anti-androgen therapy with a gonadotrophin releasing hormone agonist, including goserelin and leuprorelin, for at least the one year before the clinical onset of diabetes mellitus; or

(n)          being exposed to arsenic as specified before the clinical onset of diabetes mellitus;

Note: being exposed to arsenic as specified is defined in the Schedule 1 - Dictionary.

(8)          for gestational diabetes mellitus and type 2 diabetes mellitus only, being pregnant at the time of the clinical onset of diabetes mellitus;

(9)          having an endocrine disorder from the specified list of endocrine disorders before the clinical worsening of diabetes mellitus;

Note: specified list of endocrine disorders is defined in the Schedule 1 - Dictionary.

(10)      having a solid organ transplant or bone marrow transplant before the clinical worsening of diabetes mellitus;

(11)      having glucocorticoid therapy as specified, before the clinical worsening of diabetes mellitus, and where the glucocorticoid therapy as specified has ceased or decreased, the last dose of the therapy was received within the 30 days before the clinical worsening of diabetes mellitus;

Note: glucocorticoid therapy as specified is defined in the Schedule 1 - Dictionary.

(12)      being treated with a drug from the Specified List 1 of drugs, which cannot be ceased or substituted, for at least the seven days before the clinical worsening of diabetes mellitus;

Note: Specified List 1 of drugs is defined in the Schedule 1 - Dictionary.

(13)      being treated with a drug from the antidepressant or antipsychotic classes of drugs, which cannot be ceased or substituted, for at least the three months before the clinical worsening of diabetes mellitus;

(14)      undergoing surgery to the pancreas before the clinical worsening of diabetes mellitus;

(15)      having a specified pathological condition involving the pancreas before the clinical worsening of diabetes mellitus;

Note: specified pathological condition involving the pancreas is defined in the Schedule 1 - Dictionary.

(16)      having haemolytic uraemic syndrome before the clinical worsening of diabetes mellitus;

Note: haemolytic uraemic syndrome is defined in the Schedule 1 - Dictionary.

(17)      ingesting N-3-pyridyl methyl-N'-p-nitrophenyl urea (Vacor) within the 30 days before the clinical worsening of diabetes mellitus;

(18)      having depressive disorder at the time of the clinical worsening of diabetes mellitus;

(19)      having bipolar disorder at the time of the clinical worsening of diabetes mellitus;

(20)      having schizophrenia at the time of the clinical worsening of diabetes mellitus;

(21)      for type 2 diabetes mellitus only:

(a)          having smoked at least five pack-years of tobacco products before the clinical worsening of diabetes mellitus, and where smoking has permanently ceased, the clinical worsening of diabetes mellitus has occurred within 15 years of cessation;

Note: pack-year of tobacco products is defined in the Schedule 1 - Dictionary.

(b)          being exposed to second-hand smoke for at least 5,000 hours before the clinical worsening of diabetes mellitus, and where exposure to second-hand smoke has permanently ceased, the clinical worsening of diabetes mellitus has occurred within 15 years of cessation;

Note: being exposed to second-hand smoke is defined in the Schedule 1 - Dictionary.

(c)          being overweight or obese for at least five years before the clinical worsening of diabetes mellitus;

Note: being overweight or obese is defined in the Schedule 1 - Dictionary.

(d)         an inability to undertake moderate physical activity of at least four METs for at least the five years before the clinical worsening of diabetes mellitus;

Note: MET is defined in the Schedule 1 - Dictionary.

(e)          having cirrhosis of the liver at the time of the clinical worsening of diabetes mellitus;

(f)           having non-alcoholic steatohepatitis at the time of the clinical worsening of diabetes mellitus;

(g)          having infection with human immunodeficiency virus before the clinical worsening of diabetes mellitus;

(h)          having infection with hepatitis C virus before the clinical worsening of diabetes mellitus;

(i)            having bilateral orchiectomy before the clinical worsening of diabetes mellitus;

(j)            having anti-androgen therapy with a gonadotrophin releasing hormone agonist, including goserelin and leuprorelin, for at least the one year before the clinical worsening of diabetes mellitus; or

(k)          being exposed to arsenic as specified before the clinical worsening of diabetes mellitus;

Note: being exposed to arsenic as specified is defined in the Schedule 1 - Dictionary.

(22)      for gestational diabetes mellitus and type 2 diabetes mellitus only, being pregnant at the time of the clinical worsening of diabetes mellitus;

(23)      inability to obtain appropriate clinical management for diabetes mellitus.

10           Relationship to service

(1)          The existence in a person of any factor referred to in section 9, must be related to the relevant service rendered by the person.

(2)          The factors set out in subsections 9(9) to 9(23) apply only to material contribution to, or aggravation of, diabetes mellitus where the person's diabetes mellitus was suffered or contracted before or during (but did not arise out of) the person's relevant service.

11           Factors referring to an injury or disease covered by another Statement of Principles

In this Statement of Principles:

(1)          if a factor referred to in section 9 applies in relation to a person; and

(2)          that factor refers to an injury or disease in respect of which a Statement of Principles has been determined under subsection 196B(3) of the VEA;

then the factors in that Statement of Principles apply in accordance with the terms of that Statement of Principles as in force from time to time.

 


 

Schedule 1 - Dictionary  

Note: See Section 6

1               Definitions

 In this instrument:

                               being exposed to arsenic as specified means:

(a)           consuming drinking water with an average arsenic concentration of at least 50 micrograms per litre for a cumulative period of at least ten years; or

(b)          consuming drinking water resulting in a cumulative total arsenic exposure equivalent to having consumed drinking water containing at least 50 micrograms per litre for at least ten years; or

(c)           having clinical evidence of chronic arsenic toxicity.

                               being exposed to second-hand smoke means being in an enclosed space and inhaling smoke from burning tobacco products or smoke that has been exhaled by another person who is smoking.

                               being overweight or obese means:

(a)           having a Body Mass Index (BMI) of 25 or greater; or

(b)          having a waist circumference of greater than 80 centimetres in women or greater than 94 centimetres in men.

Note: BMI is also defined in the Schedule 1 - Dictionary.

                               BMI means W/H2 where:

(a)           W is the person's weight in kilograms; and

(b)          H is the person's height in metres.

                               diabetes mellitus—see subsection 7(2).

                               equivalent glucocorticoid therapy means a glucocorticoid in the following table, at the doses specified in the table, or a therapeutically equivalent dose of another glucocorticoid:

Glucocorticoid

Minimum cumulative dose (milligrams)

Minimum average rate (milligrams/day)

betamethasone

60

2

cortisone

1,875

62.5

dexamethasone

50

1.67

methylprednisolone

300

10

paramethasone

150

5

prednisone

375

12.5

prednisolone

375

12.5

triamcinolone

300

10

                               equivalent inhaled glucocorticoid means:

(a)           8,000 micrograms of triamcinolone;

(b)          1,600 micrograms of budesonide;

(c)           1,000 micrograms of fluticasone; or

(d)          a therapeutically equivalent dose of another inhaled glucocorticoid.

                               glucocorticoid therapy as specified means:

(a)           taking:

(i)            hydrocortisone, orally, by injection, or per rectum:

A.           to a cumulative dose of at least 1,500 milligrams, and

B.            at a minimum dose rate averaging 50 milligrams per day; or

(ii)          equivalent glucocorticoid therapy, orally, by injection, or per rectum; or

(b)          inhaling at least 1,600 micrograms of beclomethasone, or equivalent inhaled glucocorticoid, daily, for at least six months; or

(c)           using an ocular or intranasal glucocorticoid at above the maximum therapeutic dosage level, daily, for at least six months; or

(d)          applying a high or very high potency topical glucocorticoid to at least 20% of total skin surface area, daily, for at least six months; or

(e)           using a glucocorticoid concurrently with a drug from the Specified List 2 of drugs, daily, for at least 30 days.

Note: equivalent glucocorticoid therapy, equivalent inhaled glucocorticoid, high or very high potency topical glucocorticoid and Specified List 2 of drugs are also defined in the Schedule 1 – Dictionary.

                               haemolytic uraemic syndrome means a clinical syndrome characterised by renal failure, microangiopathic haemolytic anaemia and thrombocytopaenia.

                               high or very high potency topical glucocorticoid means:

(a)           betamethasone dipropionate 0.05%;

(b)          betamethasone valerate 0.1%;

(c)           clobetasol proprionate 0.05%;

(d)          diflucortolone valerate 0.1%;

(e)           fluocinolone acetonide 0.025%; or

(f)           another topical glucocorticoid of equivalent potency.

                               MET means a unit of measurement of the level of physical exertion.  1 MET = 3.5 ml of oxygen/kg of body weight per minute, 1.0 kcal/kg of body weight per hour, or resting metabolic rate.

                               MRCA means the Military Rehabilitation and Compensation Act 2004.

                               pack-year of tobacco products means:

(a)           20 cigarettes per day for a period of one calendar year; or

(b)          7,300 cigarettes in a period of one calendar year; or

(c)           7,300 grams of smoking tobacco by weight, either in cigarettes, pipe tobacco or cigars, or a combination of same, in a period of one calendar year.

                               relevant service means:

(a)           eligible war service (other than operational service) under the VEA;

(b)          defence service (other than hazardous service and British nuclear test defence service) under the VEA; or

(c)           peacetime service under the MRCA.

Note: MRCA and VEA are also defined in the Schedule 1 - Dictionary.

                               Specified List 1 of drugs means:

(a)           abacavir;

(b)          alpha and beta agonists, including adrenaline and noradrenaline;

(c)           amiodarone;

(d)          beta-blockers;

(e)           bortezomib;

(f)           cyclophosphamide;

(g)          cyclosporine;

(h)          decitabine;

(i)            diadanosine;

(j)            diazoxide;

(k)          docetaxel;

(l)            emtricitabine;

(m)        everolimus;

(n)          gatifloxacin;

(o)          growth hormone;

(p)          imatinib;

(q)          isoniazid;

(r)            L-asparaginase;

(s)           lamivudine;

(t)            levofloxacin;

(u)          moxifloxacin;

(v)          nicotinic acid for the treatment of dyslipidaemia;

(w)        nilotinib;

(x)          pentamidine;

(y)          phenytoin;

(z)           protease inhibitors;

(aa)       rifampicin;

(bb)      sirolimus;

(cc)       sodium valproate;

(dd)     somatostatin analogues;

(ee)       statins;

(ff)        stavudine;

(gg)      streptozotocin;

(hh)      tacrolimus;

(ii)          temsirolimus;

(jj)          temzolomibe;

(kk)      theophylline;

(ll)          thiazide diuretics;

(mm)  thyroid hormones;

(nn)      vorinostat; or

(oo)      zidovudine.

                               Specified List 2 of drugs means:

(a)           amprenavir;

(b)          atazanavir;

(c)           darunavir;

(d)          fosamprenavir;

(e)           indinavir;

(f)           itraconazole;

(g)          ketoconazole;

(h)          lopinavir;

(i)            nelfinavir;

(j)            ritonavir;

(k)          saquinavir; or

(l)            tipranavir.

                               specified list of endocrine disorders means:

(a)           acromegaly;

(b)          Cushing syndrome;

(c)           glucagonoma;

(d)          hyperthyroidism;

(e)           phaeochromocytoma;

(f)           primary hyperaldosteronism; or

(g)          somatostatinoma.

                               specified pathological condition involving the pancreas means:

(a)           acute pancreatitis;

(b)          chronic pancreatitis;

(c)           cystic fibrosis;

(d)          haemochromatosis; or

(e)           malignant neoplasm of the pancreas.

                               terminal event means the proximate or ultimate cause of death and includes the following:

(a)           pneumonia;

(b)          respiratory failure;

(c)           cardiac arrest;

(d)          circulatory failure; or

(e)           cessation of brain function.

                               type 1 diabetes mellitus means a form of diabetes mellitus caused by complete or near-total insulin deficiency and requiring daily administration of insulin.

                               type 2 diabetes mellitus means a form of diabetes mellitus caused by variable degrees of insulin resistance and impaired insulin secretion.

                               VEA means the Veterans' Entitlements Act 1986.